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A federal court ruling finds that FDA acted unlawfully by imposing certain REMS restrictions on mifepristone.[ Price : $8.95]
A Friends of Cancer Research working group suggests ways to overcome challenges in selecting standard of care comparators for onco...[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Zydus drug manufacturing facility in Baddi, India.[ Price : $8.95]
FDA issues a clinical hold on Intellia Therapeutics MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nexiguran ziclumeran after the co...[ Price : $8.95]
FDA clears a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer for rapid HbA1c (blood sugar) test...[ Price : $8.95]
FDA accepts for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotre...[ Price : $8.95]
Two Hyman, Phelps & McNamara attorneys report on the optimistic tone at a recent FDA public meeting on increasing U.S. drug manufa...